Characterisation of the surface properties of alpha-lactose monohydrate with inverse gas chromatography, used to detect batch variation

被引:77
作者
Ticehurst, MD
York, P
Rowe, RC
Dwivedi, SK
机构
[1] UNIV BRADFORD, SCH PHARM, BRADFORD BD7 1DP, W YORKSHIRE, ENGLAND
[2] ZENECA PHARMACEUT, MACCLESFIELD SK10 2TG, CHESHIRE, ENGLAND
[3] GLAXO INC, RES INST, RES TRIANGLE PK, NC 27709 USA
关键词
alpha-lactose monohydrate; inverse gas chromatography; surface properties; batch variation; surface free energy;
D O I
10.1016/0378-5173(96)04619-4
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Inverse gas chromatography (IGC) was employed to characterise the surface properties of four batches of alpha-lactose monohydrate supplied as chemically and physically equivalent, but reported to exhibit variable processing performance. These batches were found to be indistinguishable by FT-laser Raman spectroscopy, quantitative X-ray powder diffraction, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA) and surface area measurement. IGC was undertaken using vapours of polar and non-polar adsorbates or probes introduced individually, in very small quantities, onto the alpha-lactose monohydrate packed column. The net retention volume, V-N, of each probe was determined, allowing the calculation of various surface properties, including the dispersive component of surface free energy (gamma(D)) and specific interaction with polar probes (Delta G(A)(SP)). Whilst the gamma(D) values were comparable, Delta G(A)(SP) values for polar probes demonstrated significant differences, indicating batch variation in the polar surface properties of the four batches of alpha-lactose monohydrate. It is hypothesised that these differences in surface energetics are caused by minor variation in surface crystallinity or purity.
引用
收藏
页码:93 / 99
页数:7
相关论文
共 20 条
[1]   AMORPHOUS SURFACE AND QUANTITATIVE X-RAY-POWDER DIFFRACTOMETRY [J].
ALTREEWILLIAMS, S ;
BYRNES, JG ;
JORDAN, B .
ANALYST, 1981, 106 (1258) :69-75
[2]  
[Anonymous], ACS SYM SER
[3]  
[Anonymous], J PHARM SCI
[4]  
[Anonymous], INT J PHARM
[5]  
[Anonymous], J PHARM SCI
[6]   CONTACT-ANGLE, ADSORPTION AND WETTABILITY - A REVIEW WITH RESPECT TO POWDERS [J].
BUCKTON, G .
POWDER TECHNOLOGY, 1990, 61 (03) :237-249
[7]   ADSORPTION OF WATER ON CYCLOSPORINE-A, FROM ZERO TO FINITE SURFACE COVERAGE [J].
DJORDJEVIC, NM ;
ROHR, G ;
HINTERLEITNER, M ;
SCHREIBER, B .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1992, 81 (01) :21-29
[8]   GAS-CHROMATOGRAPHIC ANALYSIS OF ANOMERIC COMPOSITION OF LACTOSE [J].
DWIVEDI, SK ;
MITCHELL, AG .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1989, 78 (12) :1055-1056
[9]   HEATS OF ADSORPTION OF SMALL MOLECULES ON VARIOUS FORMS OF LACTOSE, SUCROSE, AND GLUCOSE [J].
EHLER, KF ;
BERNHARD, RA ;
NICKERSON, TA .
JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY, 1979, 27 (05) :921-927
[10]   GAS-LIQUID PARTITION CHROMATOGRAPHY - THE SEPARATION AND MICRO-ESTIMATON OF VOLATILE FATTY ACIDS FROM FORMIC ACID TO DODECANOIC ACID [J].
JAMES, AT ;
MARTIN, AJP .
BIOCHEMICAL JOURNAL, 1952, 50 (05) :679-690